Rounding Summaries for Families of Critically Ill Patients
8 marzo 2021 aggiornato da: Jared Greenberg, Rush University Medical Center
Many patients in intensive care units (ICUs) rely on family members or surrogates to make medical decisions on their behalf. One of the recommended ways to improve a surrogate's experience is to invite him or her to participate in daily, multidisciplinary ICU rounds. In practice, this is often a challenging way for clinicians to engage with the patient's surrogates.
Surrogates of non-decisional ICU patients will be randomized to receive a written rounding summary every day or every other day that the patient is in the ICU. The summary will be organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.
The investigators hypothesize that surrogates who receive written rounding summaries will be more satisfied with ICU care than surrogates who receive usual care. Satisfaction will be measured by the Critical Care Family Needs Inventory (CCFNI) questionnaire.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
252
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60612
- Rush University Medical Center
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Patients in the adult Medical and Cardiac ICUs at Rush University Medical Center will be prospectively screened.
Inclusion criteria (Patient characteristics required for surrogate inclusion) At least one of the following
- The patient has required invasive or non-invasive mechanical ventilation for at least three consecutive days.
- The patient has an expected in-hospital mortality rate of at least 25% according to the primary ICU physician.
Exclusion criteria (Patient characteristics that will exclude surrogates from study enrollment):
- The patient possesses decisional capacity at the time of enrollment.
- The patient has required invasive or non-invasive mechanical ventilation for more than the previous 14 days
- The patient is expected to die or transition to comfort care within the next 48 hours based on ICU physician estimate.
- The patient is expected to be liberated from mechanical ventilation (if applicable) or discharged from the ICU within the next 24 hours.
- There is no identifiable surrogate.
- The patient is member of a vulnerable population i.e. pregnant, prisoner.
- The ICU physician refuses permission to approach surrogates for consent
The investigators will hand out fliers that describe the study to surrogates of patients who are expected to meet the above criteria. Surrogates can ask the nurse to contact the lead investigator if they are interested in learning more about the study. If no surrogate is present prior to the patient meeting the inclusion criteria, the investigators will attempt to contact the surrogate by phone to provide information on the study.
One surrogate will be approached for informed consent and enrolled based on the following criteria.
Inclusion criteria for surrogate decision maker:
- Age ≥ 18 years old
- Self-identified as participating directly in health care decision making for the incapable patient
Exclusion criteria for surrogate decision makers:
- The surrogate does not agree to participate in study procedures (surveys, interviews)
- The surrogate needs translation assistance because of poor English fluency
- The surrogate has history of a clinically important neurological disorder (e.g., dementia)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Rounding Summary
Surrogates who are assigned to the intervention group will receive a written rounding summary every day or every other day that the patient is in the ICU. The summary will be organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening. For patients assigned to the intervention group, the investigators will forward the previous day's summary to the ICU nurse at the beginning of each day shift. After participating in morning rounds, ICU nurses will be asked to modify the summary based on the plan for the day. Nurses will be asked to use the written summary to guide communication with surrogates that day. |
Written summary of rounds
|
|
Nessun intervento: Usual Care
Usual ICU care
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Lasso di tempo: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire.
14 questions.
Total score range 14-56 with lower scores indicating better satisfaction.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Surrogate Anxiety and Depression
Lasso di tempo: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Score on Hospital Anxiety and Depression Scale (HADS).
Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions).
Higher scores indicate greater symptom burden.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
|
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Lasso di tempo: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Score on Impact of Events Scale Revised (IES-R) questionnaire.
22 questions.
Score 0-88 with higher scores indicating more stress.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
|
Surrogate and physician agreement regarding the patient's condition
Lasso di tempo: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Surrogates and ICU physicians will be provided with a list of common medical ICU diagnoses.
Respondents will be asked to indicate which of these diagnoses, if any, pertain to the patient.
When the respondent picks a diagnosis, he or she will be prompted to indicate whether common treatments for that condition are being provided.
Finally, for each checked diagnosis, the respondent will indicate whether he or she believes the problem is "getting better, getting worse, or staying the same."
Members of the research team, blinded to the surrogates' treatment arm, will evaluate for inter-rater agreement between surrogates and ICU physician responses.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
|
Change in Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
Lasso di tempo: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
Change in Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire.
14 questions.
Total score range 14-56 with lower scores indicating better satisfaction.
|
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
|
Change in Surrogate Anxiety and Depression
Lasso di tempo: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
Change in Score on Hospital Anxiety and Depression Scale (HADS).
Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions).
Higher scores indicate greater symptom burden.
|
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
|
Change in Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Lasso di tempo: From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
Change in score on Impact of Events Scale Revised (IES-R) questionnaire.
22 questions.
Score 0-88 with higher scores indicating more stress.
|
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Qualitative feedback from participating surrogates
Lasso di tempo: Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
All surrogates will be asked to participate in a 10-15 minute phone or in-person interview.
This interview will deal with their satisfaction with the patient's care and communication with the ICU staff.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
|
Feedback from participating nurses
Lasso di tempo: Daily while patient is in the ICU
|
Nurses of enrolled patients/surrogates will be asked to complete an online survey regarding communication with the patient and/or surrogates that day.
Nurses will also be invited to participate in focus groups to provide feedback.
|
Daily while patient is in the ICU
|
|
Surrogate Satisfaction with Patient Care
Lasso di tempo: Measured once 10-14 days after enrollment if patient still in ICU
|
Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire.
14 questions.
Total score range 14-56 with lower scores indicating better satisfaction.
|
Measured once 10-14 days after enrollment if patient still in ICU
|
|
Surrogate Anxiety and Depression
Lasso di tempo: Measured once 10-14 days after enrollment if patient still in ICU
|
Score on Hospital Anxiety and Depression Scale (HADS).
Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions).
Higher scores indicate greater symptom burden.
|
Measured once 10-14 days after enrollment if patient still in ICU
|
|
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
Lasso di tempo: Measured once 10-14 days after enrollment if patient still in ICU
|
Score on Impact of Events Scale Revised (IES-R) questionnaire.
22 questions.
Score 0-88 with higher scores indicating more stress.
|
Measured once 10-14 days after enrollment if patient still in ICU
|
|
Surrogate and physician agreement regarding the patient's condition
Lasso di tempo: Measured once 10-14 days after enrollment if patient still in ICU
|
Surrogates and ICU physicians will be provided with a list of common medical ICU diagnoses.
Respondents will be asked to indicate which of these diagnoses, if any, pertain to the patient.
When the respondent picks a diagnosis, he or she will be prompted to indicate whether common treatments for that condition are being provided.
Finally, for each checked diagnosis, the respondent will indicate whether he or she believes the problem is "getting better, getting worse, or staying the same."
Members of the research team, blinded to the surrogates' treatment arm, will evaluate for inter-rater agreement between surrogates and ICU physician responses.
|
Measured once 10-14 days after enrollment if patient still in ICU
|
|
Patient length of mechanical ventilation (if applicable)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
Patient length of mechanical ventilation (if applicable)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Patient failed extubation attempt (yes/no) (if applicable)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
Failed extubation attempt (yes/no) (if applicable)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Tracheostomy placement during ICU admission (yes/no)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
Tracheostomy placement during ICU admission (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Days from intubation to tracheostomy placement (if applicable)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
Days from intubation to tracheostomy placement (if applicable)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
ICU discharge requiring invasive mechanical ventilation (yes/no)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
ICU discharge requiring invasive mechanical ventilation (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
ICU discharge requiring new artificial nutritional supplementation (yes/no)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
ICU discharge requiring new artificial nutritional supplementation (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
ICU discharge requiring new renal replacement therapy (yes/no)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
ICU discharge requiring new renal replacement therapy (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Change in code status or limitations to care during ICU stay (yes/no)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
Change in code status or limitations to care during ICU stay (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Days from ICU admission to change in code status or new limitations to care (if applicable)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
Days from ICU admission to change in code status or new limitations to care (if applicable)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
ICU length of stay (days)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
ICU length of stay (days)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Hospital length of stay (days)
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
Hospital length of stay (days)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Hospital disposition
Lasso di tempo: Measured during hospitalization, up to 90 days after enrollment.
|
Hospital disposition
|
Measured during hospitalization, up to 90 days after enrollment.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Brown SM, Rozenblum R, Aboumatar H, Fagan MB, Milic M, Lee BS, Turner K, Frosch DL. Defining patient and family engagement in the intensive care unit. Am J Respir Crit Care Med. 2015 Feb 1;191(3):358-60. doi: 10.1164/rccm.201410-1936LE. No abstract available.
- Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
- Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
- Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.
- Greenberg JA, Basapur S, Quinn TV, Bulger JL, Schwartz NH, Oh SK, Shah RC, Glover CM. Challenges faced by families of critically ill patients during the first wave of the COVID-19 pandemic. Patient Educ Couns. 2022 Feb;105(2):297-303. doi: 10.1016/j.pec.2021.08.029. Epub 2021 Aug 27.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 giugno 2019
Completamento primario (Effettivo)
11 gennaio 2021
Completamento dello studio (Effettivo)
12 febbraio 2021
Date di iscrizione allo studio
Primo inviato
10 maggio 2019
Primo inviato che soddisfa i criteri di controllo qualità
29 maggio 2019
Primo Inserito (Effettivo)
31 maggio 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 marzo 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 marzo 2021
Ultimo verificato
1 marzo 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 19042604
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .